AstraZenec?a Announces Initiation of Two Additional Global Studies for BRILINTA (Ticagrelo?r)

AstraZeneca has announced plans to conduct two new Phase IIIb clinical studies as part of PARTHENON, the company's largest clinical trial programme involving over 80,000 patients, with Canada actively participating in both studies. The studies are designed to build scientific understanding of BRILINTA (ticagrelor) tablets in additional high-risk patient populations.

SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES) is a global clinical trial involving 9600 patients who have experienced an acute ischaemic stroke or transient ischaemic attack (TIA). Annually, 50,000 Canadians suffer a stroke. It is the third leading cause of death in Canada.(1) Ischaemic strokes occur as a result of an obstruction of a vessel supplying blood to the brain.(2) A TIA is secondary to a temporary insufficient blood supply to parts of the brain and is often considered a warning sign that a stroke may follow.( 3)

SOCRATES is a randomised, parallel group study evaluating the efficacy of ticagrelor compared with aspirin in reducing major vascular events (composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke) in patients with acute ischaemic stroke (NIHSS < 5).

"The short-term stroke risk after a TIA and minor ischaemic stroke is extremely high, with more than 10% of patients having a major stroke within 90 days; and this is with aspirin. We need better medicines in this setting and SOCRATES will tell us whether ticagrelor might be such a medicine," said Clay Johnston, MD, PhD Director,   Clinical and Translational Science Institute, Associate Vice Chancellor of Research, University of California, San Francisco.

THEMIS (Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study) is a global clinical trial involving 17,000 patients with Type 2 diabetes at high risk of cardiovascular events. More than nine million Canadians are currently living with diabetes or pre-diabetes(4) and approximately 90% of those affected are Type 2.(5)

"A major goal for treating patients with diabetes is to reduce their cardiovascular risk," said THEMIS study co-chair Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School and Senior Physician at Brigham and Women's Hospital.

THEMIS is an event-driven, randomised, parallel group study comparing the efficacy of long-term treatment with ticagrelor versus placebo for the prevention of major cardiovascular events (composite of cardiovascular death, myocardial infarction or stroke) in patients with Type 2 diabetes without a history of previous myocardial infarction or stroke, but with documented coronary atherosclerosis. Study patients will receive ticagrelor 90 mg twice daily versus placebo and will be managed according to local standards of care, including provision of dietary and lifestyle advice according to local diabetes treatment guidelines. Use of low-dose aspirin once daily is permitted if clinically indicated, as judged by the investigator.

"THEMIS will allow us to test a new strategy in the care of patients with diabetes who are at high risk of myocardial infarction, stroke, and cardiovascular death," stated THEMIS study co-chair Ph. Gabriel Steg, MD, Professor of Medicine at Université Paris-Diderot and Director of the Coronary Care Unit at Hôpital Bichat.

SOCRATES and THEMIS will be monitored by Independent Data Monitoring Committees who will review the safety and efficacy of treatments in these trials. The trials will be conducted in accordance with Good Clinical Practice. Both studies will be posted on clinicaltrials.gov in the near future.

AstraZeneca is currently collaborating with more than 4000 clinical investigators in more than 30 countries as part of the PARTHENON  programme, and has established partnerships with a number of pre-eminent research institutions. Other studies in the PARTHENON programme include PEGASUS, studying ticagrelor for secondary prevention in patients with previous myocardial infarction, and EUCLID studying patients with Peripheral Artery Disease.

PARTHENON will provide a huge dataset to build scientific understanding of ticagrelor in a broad a range of atherothrombotic conditions.

Ticagrelor is currently not approved for the treatment of patients with ischaemic stroke, Peripheral Artery Disease, or for secondary prevention in patients with a history of previous myocardial infarction going back more than one year.

References

(1) www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.htm#stroke

(2) www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/IschemicClots/Ischemic-Strokes-Clots_UCM_310939_Article.jsp

(3) www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/TIA/TIA-Transient-Ischemic-Attack_UCM_310942_Article.jsp

(4) www.diabetes.ca/about-diabetes/what/prevalence/

(5) www.diabetes.ca/diabetes-and-you/what/facts